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Induction PD-1 Inhibitor and Chemotherapy Followed by Chemoradiotherapy in Unresectable or Inoperable HPV-negative LA-HNSCC

NCT07776340 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-08-20

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate if adding chemotherapy and immunotherapy as induction treatment prior to definitive chemoradiotherapy could improve the outcomes of locally advanced HPV-negative head and neck squamous cell that are not amenable to surgery. The study aims to answer:

1. Does this treatment improve the survival outcomes of participants?
2. How do the tumors of participants response to the treatment?
3. How is the safety of this treatment? Researchers will compare this treatment (induction chemoimmunotherapy, followed by concurrent chemoradiotherapy, and then immunotherapy as maintenance therapy) to concurrent chemoradiotherapy to see whether it provides additional clinical benefits.

Conditions

  • HPV-unrelated Head and Neck Squamous Cell Carcinoma

Interventions

BIOLOGICAL

Tislelizumab

* As induction immunotherapy, 200 mg administered IV infusion on Day 1 of each 21-day cycle, for 3 cycles. * As adjuvant immunotherapy, 200 mg administered IV infusion on Day 1 of each 21-day cycle, for 13 cycles.

DRUG

Paclitaxel

\- As induction chemotherapy, 175 mg/m2 administered IV infusion on Day 2 of each 21-day cycle, for 3 cycles.

DRUG

Cisplatin (75 mg/m2)

\- As induction chemotherapy, 75 mg/m2 administered IV infusion on Day 2-4 of each 21-day cycle, for three cycles.

RADIATION

Intensity-Modulated Radiotherapy

\- Definitive IMRT: 70Gy given in 35 fractions over 7 weeks

DRUG

Cisplatin (80 mg/m2)

\- As concurrent chemotherapy, 80 mg/m2 administered IV infusion on Day 1-3 of each 21-day cycle, for two cycles.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-12-31
Completion
2030-03-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07776340 on ClinicalTrials.gov